openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20NXAC005 20LXAC098 20NXAC037 20NXAC039 Additional affected lots as of 3/17/21: 20NXAC008 20LXAC063
Distribution pattern
US Nationwide distribution.
device · product 2 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC042
Distribution pattern
US Nationwide distribution.
device · product 3 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC061 20NXAC036 20LXAC062 Additional affected lots as of 3/17/21: 20LXAC099 20LXAC086 20NXAC014
Distribution pattern
US Nationwide distribution.
device · product 4 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20NXAC034
Distribution pattern
US Nationwide distribution.
device · product 5 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC048 20LXAC053 20LXAC047 20NXAC016 20LXAC094 20NXAC009 20LXAC049 20LXAC054 20NXAC025 20NXAC024 Additional Affected lots as of 3/17/21: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 20NXAC016
Distribution pattern
US Nationwide distribution.
device · product 6 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC056 20LXAC057 20NXAC038 20LXAC041 20LXAC055 Additional affected lots as of 3/17/21: 20NXAC013 20NXAC035
Distribution pattern
US Nationwide distribution.
device · product 7 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC097 Additional affected lot as of 3/17/21: 20NXAC033
Distribution pattern
US Nationwide distribution.
device · product 8 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC038 20NXAC032
Distribution pattern
US Nationwide distribution.
device · product 9 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC090 20NXAC044
Distribution pattern
US Nationwide distribution.
device · product 10 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC043 20LXAC044 20LXAC045 20LXAC059 20LXAC060 20LXAC079 20LXAC095 20NXAC026 Additional lots as of 3/17/21: 20LXAC078 20NXAC012 20LXAC058 20LXAC096 20NXAC011
Distribution pattern
US Nationwide distribution.
device · product 11 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC092 20NXAC006 20NXAC027
Distribution pattern
US Nationwide distribution.
device · product 12 of 19
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC052 Additional affected lot as of 3/17/21: 20LXAC088
Distribution pattern
US Nationwide distribution.
device · product 13 of 19
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC034 20LXAC069 20NXAC040
Distribution pattern
US Nationwide distribution.
device · product 14 of 19
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC018
Distribution pattern
US Nationwide distribution.
device · product 15 of 19
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC070 20LXAC103 20NXAC021 20LXAC100 20LXAC026 20LXAC027 20LXAC028 20LXAC029 20LXAC065 20LXAC067 20LXAC071 20NXAC001 20NXAC019 20NXAC020 20NXAC029 Additional affected lots as of 3/17/21: 20LXAC103 20LXAC082 20LXAC025 20LXAC081 20LXAC083
Distribution pattern
US Nationwide distribution.
device · product 16 of 19
NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC024 20LXAC072 20LXAC073 20LXAC085 20NXAC017 20NXAC030 20LXAC074 20LXAC023 20LXAC104 Additional affected lots as of 3/17/21: 20LXAC066 20LXAC089
Distribution pattern
US Nationwide distribution.
device · product 17 of 19
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC051
Distribution pattern
US Nationwide distribution.
device · product 18 of 19
Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information
Lot Numbers: 20LXAC031 Additional affected lots as of 3/17/21: 20NXAC004 20LXAC033 20NXAC003 20LXAC032
Distribution pattern
US Nationwide distribution.
device · product 19 of 19
Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
